3/17 Taiwan Life Sciences Biweekly Newsletter
2025-03-17 |
| Taiwan Life Sciences Biweekly |
| Ministry to standardize electronic medical data 13 March, 2025 The Ministry of Health and Welfare yesterday announced that it would launch an online medical information platform, saying that its short-term goal is facilitating the sharing of healthcare data between medical centers, so that patients would not need to request copies of their files. More... |
| UnicoCell Biomed's new drug receives US FDA Fast Track designation 12 March, 2025 UnicoCell Biomed (TW: 6794) announced that its allogeneic adipose-derived stem cell product ELIXCYTE, designed for the treatment of chronic kidney disease, has been granted Fast Track designation by the US FDA. With Phase I/II clinical trials for its chronic kidney disease treatment already completed, UnicoCell Biomed stated that receiving Fast Track status highlights the FDA's recognition of ELIXCYTE's potential as an innovative treatment for chronic kidney disease and also allows the company to expedite subsequent clinical trials and the market approval process. More... (in Chinese) |
| Taiwan Bio Therapeutics expands US footprint, partners with Mayo Clinic to develop next-generation cell therapy products 12 March, 2025 Taiwan Bio Therapeutics (TW: 6892) has signed a Letter of Intent (LOI) with the Mayo Clinic of the United States to jointly develop an innovation park in Phoenix, US, focusing on breakthrough cell therapy production technologies. The collaboration will cover the full process from cell preparation to clinical infusion (so-called "needle-to-needle" process) using Taiwan Bio Therapeutics' FAST CGT platform. This partnership aims to address high labor costs and shortages in the US through decentralized and automated production, ultimately enhancing the efficiency, reducing costs, and shortening the production cycles of cell therapies, and making cell therapies accessible to more patients. More... (in Chinese) |
| Sunhawk Vision Biotech: A key player in eye drop development 11 March, 2025 Sunhawk Vision Biotech (TW: 7759) was officially listed on the Taipei Exchange on the 10th of March, marking its entry into the capital market. The company is advancing the first-in-human clinical trial of its anti-microRNA-328 eye drop (SHJ002) for pediatric use. At a concentration of 0.25 percent (2,500 ?g/mL), SHJ002 has demonstrated good safety and tolerability, making it the first such anti-microRNA-based therapy tested in ophthalmology. This innovative treatment has the potential to control myopia in children, with further Phase II and III trials required to assess its long-term efficacy and safety. More... (in Chinese) |
| Immunwork showcases new drug in international journal 11 March, 2025 Immunwork, founded by Chang Tzu-Wen, renowned for his achievements in developing new antibody drugs, announced that its ultra-long-acting peptide drug, TE-8105, developed using innovative fatty acid conjugation technology, was featured in the Journal of Medicinal Chemistry. The study revealed that TE-8105 outperforms the well-known GLP-1 receptor agonist semaglutide in treating obesity (including weight management), type 2 diabetes, and non-alcoholic fatty liver disease (NAFLD). More... (in Chinese) |
| Health2Sync eyes Taiwan IPO with US$20M Series C fund 10 March, 2025 [Taiwan's] Digital chronic disease management platform Health2Sync has recently raised US$20 million in a Series C funding round led by Taiwania Capital. Wistron, Pegatron, BE Health Ventures, ABIES Capital, and Cathay Venture also joined the round. This latest investment brings its total capital raised since its founding in 2013 to over US$30 million. More... |
| Taiwan biopharmaceutical startup takes page from TSMC's playbook 9 March, 2025 A Taiwanese biopharmaceutical startup aspires to become a global player via the same tactics that compatriot Taiwan Semiconductor Manufacturing Co. employed to find success in the chip sector, extending Taiwan's so-called silicon shield into new domains. Founded in 2023, Taiwan Bio-Manufacturing Corp. is a contract manufacturer of cutting-edge treatments that use messenger RNA, gene therapy, cell therapy and biologics. Many of its roughly 100 staffers previously worked for government-backed research institutes. More... |
| Taiwan flexes medical tech prowess at HIMSS 2025 7 March, 2025 A delegation organized by the National Science and Technology Council attended the global conference and exhibition of the US-based Healthcare Information and Management Systems Society March 3-6 in Las Vegas. According to the NSTC, the group comprised representatives from five hospitals around the country that showcase Taiwan's strengths in artificial intelligence-enhanced healthcare, telecare and health data applications. More... |
| Amaran Biotech Signs MOU with Nippon Fine Chemical Joining Forces with Zillion Fine Chemicals to Expand CDMO Business Press release 7 March, 2025 Amaran Biotechnology Inc., a subsidiary of OBI Pharma specializing in Contract Development and Manufacturing Organization (CDMO) services for next-generation pharmaceuticals, announced today that it has signed a Memorandum of Understanding (MOU) with Nippon Fine Chemical Co., Ltd., and its Taiwan subsidiary, Zillion Fine Chemicals International Co., Ltd. The three parties aim to deepen collaboration in the field of nanoparticle-based drug CDMO manufacturing while expanding their presence in Taiwan, Japan, and international CDMO markets. More... |
| Enimmune's enterovirus vaccine set to enter Southeast Asian markets 7 March, 2025 Adimmune's (TW: 4142) subsidiary, Enimmune (TW: 6564), announced the complete Phase III clinical trial data for its Enterovirus 71 vaccine (EnVAX-A71), showing an impressive 99.21 percent efficacy. The vaccine was 100 percent effective in reducing the risk of hospitalization due to Enterovirus 71 infections. With excellent protection and safety data, Enimmune plans to expand into Southeast Asia, where enterovirus outbreaks are prevalent. The company submitted a drug registration application to Macau in late February. The company mentioned that the vaccine, approved by Taiwan's FDA in 2023, uses the locally prevalent B4 strain of the virus and leverages Adimmune’s new high-capacity cell culture bioreactor process, enabling significant increases in production capacity starting this year to meet growing demand. More... (in Chinese) |
| Energenesis Biomedical and Phison Electronics sign MOU to promote AI drug development 6 March, 2025 Energenesis Biomedical (TW: 6657) has partnered with Phison Electronics (TW: 8299) through a memorandum of understanding (MOU) to enhance its AI drug development by utilizing Phison's aiDAPTIV+ solution. This collaboration aims to reduce development costs, speed up drug repurposing, and shorten time-to-market, addressing unmet medical needs. The company highlighted that generative AI (GenAI) could potentially compress a traditionally decade-long development process to just one to two years, transforming the drug development landscape and reshaping commercialization strategies, with those leveraging this trend having a competitive advantage. More... (in Chinese) |
| Taimed Biologics and Helios Pharmaceuticals form strategic partnership to jointly promote new HIV drug in Vietnam 6 March, 2025 Taimed Biologics (TW: 4147) announced that it had entered a strategic partnership with Vietman's Helios Pharmaceutical for the promotion of the new HIV drug Trogarzo in Vietnam. The specific terms of the agreement are confidential and not disclosed. According to the partnership terms, Helios Pharmaceutical will be responsible for the application for the drug’s regulatory approval and its promotion and commercialization in the agreed-upon region. More... (in Chinese) |
| TAHO Pharma aims to complete licensing of its anti-thrombosis oral film drug by year-end 5 March, 2025 TAHO Pharmaceutical (TW: 6467) plans to apply for regulatory approval in Europe and the US for its anti-thrombosis oral film drug TAH3311 in the third quarter of this year, following successful data analysis from its US pivotal study. The company aims to complete licensing by year-end and launch the drug as early as next year, while also preparing for an IPO in mid-2025. A preliminary report released in February confirmed TAH3311's efficacy is nearly equivalent to the original drug, with a full report expected in April. TAHO will also initiate licensing negotiations across different regions in the US and Europe. More... (in Chinese) |
| UnicoCell Biomed obtains PIC/S GMP pilot plant certification after passing MoHW inspection 5 March, 2025 Unicocell Biomed (TW: 6794) announced that it has obtained PIC/S GMP pilot plant certification after passing the Ministry of Health and Welfare's (MoHW) inspection, advancing its preparations for drug approval in its Phase III clinical trials for degenerative knee osteoarthritis. The certification also enables the company to expand its CDMO business in regenerative medicine cell therapy. In addition, Unicocell Biomed recently formed a partnership with the Mantu Group to enter the hair care market with exosome products. The PIC/S GMP-certified plant will support the production of approved drugs and assist hospitals in providing high-quality cell-based treatments. The facility has also received certification from Japan's Ministry of Health, Labor, and Welfare for specific cell processing products. More... (in Chinese) |
| Advagene Biopharma's nasal spray drug for severe asthma meets exploratory Phase II clinical trial endpoints 5 March, 2025 Advagene Biopharma (TW: 6709) announced that the exploratory Phase II clinical trial results of its severe asthma nasal spray drug AD17002 not only met safety standards but also significantly improved lung function, alleviated inflammation, and reduced eosinophil counts in both blood and sputum. The clinical trial results will be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in March. More... (in Chinese) |
| Researchers at NTHU and NHRI develop new drug for treating chronic intestinal inflammation 5 March, 2025 Assistant Professor Yu-Hsin Chiu from National Tsing Hua University (NTHU) in Taiwan and Director Hsing-Pang Hsieh of the National Health Research Institutes (NHRI) have developed a drug to treat chronic intestinal inflammation, driven by modern stress and poor diets, causing diarrhea and indigestion. By blocking ion channels on intestinal cells, this breakthrough, published in Advanced Science, offers new hope. More... |
| Seven biotech companies keeping Taiwan dynamic in 2025 5 March, 2025 Taiwan has a population of approximately 23 million and is often recognized for its high-tech industries, particularly electronics. However, over the past two decades, the country has also invested in building a competitive biotechnology sector. Given its limited domestic market but strong infrastructure in manufacturing, research, and data-driven industries, Taiwan has positioned itself as a regional biotech player, focusing on precision medicine, immunotherapy, and drug development. More... |
| Taiwan's Formosa Group invests US$12.5M to establish biomedical research centre in Korea 5 March, 2025 Taiwan-based Formosa Group Executive Committee member and Chairman Sandy Wang, who leads the group's bio and eco-friendly energy sectors, recently announced the decision to establish a bio-medical research centre within Korea Advanced Institute of Science and Technology (KAIST) and invest approximately KRW 18 billion (US$12.5 million) or more over 5 years. More... |
| EirGenix applies for Phase III clinical trial of EG1206A, targeting global breast cancer treatment market 3 March, 2025 EirGenix (TW: 6589) has applied to Taiwan’s TFDA for a Phase III clinical trial of its second-generation biosimilar EG1206A for early-stage and metastatic breast cancer, following approval from the US FDA. The drug will undergo multi-center trials in several countries, with plans for further regulatory submissions. Specializing in breast cancer treatments, EirGenix is advancing multiple biopharmaceutical and biosimilar projects, aiming to launch a Phase III trial for EG1206A this year and secure approvals in Europe and the US by 2027. More... (in Chinese) |
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